公开(公告)号：US5496302A

公开(公告)日：1996-03-05

申请号：US876125

申请日：1992-04-29

申请人： Billy W. Minshall ,  John E. Nygard ,  Kwame Sintim-Damoa ,  Richard Giesler ,  Archie Woodworth ,  Kailash Purohit

发明人： Billy W. Minshall ,  John E. Nygard ,  Kwame Sintim-Damoa ,  Richard Giesler ,  Archie Woodworth ,  Kailash Purohit

IPC分类号： A61L2/00 ,  A61L2/04 ,  A61L2/08 ,  A61L2/20 ,  A61M1/02 ,  A61B19/00

CPC分类号： A61L2/20 ,  A61L2/0023 ,  A61L2/08 ,  A61M1/0209

摘要： Methods are disclosed for sterilizing a selected portion of a product and for assembling a sterile product from two or more parts which can not be sterilized with the same form of sterilization. A sterile product produced by these methods is also disclosed. The method for sterilizing may include sterilizing a selected portion of the product by exposing the selected portion to an electron beam, while shielding the remainder of the product from the radiation of the electron beam. The method of assembling a sterile product from two or more component parts may include the steps of sterilizing the first part of the product, isolating a portion of the first part from the remainder of the first part, attaching the second part to the isolated portion of the first part, and exposing the isolated portion to a form of sterilization which is deleterious to the remainder of the first part, while shielding the remainder of the first part from such form of sterilization.

摘要翻译： 公开了用于对产品的选定部分进行灭菌并组装来自两个或更多个部件的无菌产品的方法，所述两个或更多部分不能用相同形式的灭菌灭菌。 还公开了通过这些方法生产的无菌产品。 灭菌方法可以包括通过将所选择的部分暴露于电子束来对产品的选定部分进行消毒，同时屏蔽产品的剩余部分与电子束的辐射。 从两个或多个组成部件组装无菌产品的方法可以包括以下步骤：消除产品的第一部分，将第一部分的一部分与第一部分的其余部分隔离，将第二部分附接到第 第一部分，并将分离的部分暴露于对第一部分的其余部分有害的灭菌形式，同时将第一部分的其余部分从这种形式的灭菌中屏蔽。

公开(公告)号：US5009654A

公开(公告)日：1991-04-23

申请号：US321698

申请日：1989-03-10

申请人： Billy W. Minshall ,  Kailash Purohit ,  John E. Nygard ,  Kwame Sintim-Damoa ,  Richard Giesler ,  Archie Woodworth

发明人： Billy W. Minshall ,  Kailash Purohit ,  John E. Nygard ,  Kwame Sintim-Damoa ,  Richard Giesler ,  Archie Woodworth

IPC分类号： A61L2/00 ,  A61L2/04 ,  A61L2/08 ,  A61L2/20 ,  A61M1/02

CPC分类号： A61L2/20 ,  A61L2/0023 ,  A61L2/08 ,  A61M1/0209

摘要： Methods are disclosed for sterilizing a selected portion of a product and for assembling a sterile product from two or more parts which can not be sterilized with the same form of sterilization. A sterile product produced by these methods is also disclosed. The method for sterilizing may include sterilizing a selected portion of the product by exposing the selected portion to an electron beam, while shielding the remainder of the product from the radiation of the electron beam. The method of assembling a sterile product from two or more component parts may include the steps of sterilizing the first part of the product, isolating a portion of the first part from the remainder of the first part, attaching the second part to the isolated portion of the first part, and exposing the isolated portion to a form of sterilization which is deleterious to the remainder of the first part, while shielding the remainder of the first part from such form of sterilization.

摘要翻译： 公开了用于对产品的选定部分进行灭菌并组装来自两个或更多个部件的无菌产品的方法，所述两个或更多部分不能用相同形式的灭菌灭菌。 还公开了通过这些方法生产的无菌产品。 灭菌方法可以包括通过将所选择的部分暴露于电子束来对产品的选定部分进行消毒，同时屏蔽产品的剩余部分与电子束的辐射。 从两个或多个组成部件组装无菌产品的方法可以包括以下步骤：消除产品的第一部分，将第一部分的一部分与第一部分的其余部分隔离，将第二部分附接到第 第一部分，并将分离的部分暴露于对第一部分的其余部分有害的灭菌形式，同时将第一部分的其余部分从这种形式的灭菌中屏蔽。

公开(公告)号：US20050133729A1

公开(公告)日：2005-06-23

申请号：US10744242

申请日：2003-12-23

申请人： Archie Woodworth ,  William Reed ,  David Adams ,  John Martine ,  Jeffery Smith ,  Michael Steeber ,  Kim Korzeniewski

发明人： Archie Woodworth ,  William Reed ,  David Adams ,  John Martine ,  Jeffery Smith ,  Michael Steeber ,  Kim Korzeniewski

IPC分类号： A61J1/00 ,  A61J1/20 ,  A61L2/00 ,  A61L2/08 ,  A61M5/00 ,  A61M39/18 ,  B65B35/30 ,  H01J37/20 ,  G01N23/00

CPC分类号： A61M5/008 ,  A61J1/10 ,  A61J1/1475 ,  A61J1/201 ,  A61J1/2013 ,  A61J1/2051 ,  A61J1/2055 ,  A61J1/2089 ,  A61L2/0011 ,  A61L2/087 ,  A61L2202/122

摘要： What is disclosed is an apparatus and method for assembling a reconstitution assembly (1) having a reconstitution device (10) having a first end connected to a flexible diluent container (12), the reconstitution device (10) having a second end connected to a drug vial (14). The reconstitution device (10) and containers, such as drug vials (14) or diluent bags (12), are loaded onto positioning assemblies (27) on a conveyor (90). The positioning assemblies (27) are conveyed to sterilization booths (270). Sterilization fields are generated within the sterilization booths (270), and the containers are sterilely connected to the reconstitution device (10) within the sterile fields.

摘要翻译： 所公开的是用于组装具有重构装置（10）的重构组件（1）的装置和方法，所述重构装置具有连接到柔性稀释剂容器（12）的第一端，所述重构装置（10）的第二端连接到 药瓶（14）。 重建装置（10）和诸如药物小瓶（14）或稀释袋（12）的容器被装载到传送器（90）上的定位组件（27）上。 定位组件（27）被输送到灭菌室（270）。 消毒场在灭菌室（270）内产生，容器与无菌区内的重建装置（10）无菌连接。

公开(公告)号：US07655198B2

公开(公告)日：2010-02-02

申请号：US11323112

申请日：2005-12-30

申请人： Arnold C. Bilstad ,  Bradley H. Buchanan ,  Alan W. Martilla ,  Archie Woodworth

发明人： Arnold C. Bilstad ,  Bradley H. Buchanan ,  Alan W. Martilla ,  Archie Woodworth

IPC分类号： A61L2/00 ,  A61L9/00 ,  B29C65/00 ,  B32B37/00 ,  B29C65/10 ,  B31F5/00 ,  B65H19/00 ,  B65H69/02 ,  G03D15/04

CPC分类号： A61L2/00 ,  A61L2/08 ,  A61L2/087 ,  A61L2/14 ,  A61L2/208 ,  A61L2202/23 ,  A61L2202/24 ,  A61M39/18 ,  B29C65/02 ,  B29C65/04 ,  B29C65/103 ,  B29C65/4895 ,  B29C66/0018 ,  B29C66/1142 ,  B29C66/5221 ,  B29C66/5229 ,  B29C66/52293 ,  B29C66/52298 ,  B29C66/73921 ,  B29C66/81431 ,  B29C66/83221 ,  B29C66/857 ,  B29L2023/007 ,  B67C7/0073

摘要： The connection, assembly, or fill of two or more pre-sterilized components having at least one terminal end each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field. Using a low-voltage electron beam instrument, such as the MIN-EB™, a suitable sterile field sphere can be created. The terminal ends of the multiple components remain within the sterile field sphere until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

摘要翻译： 公开了具有至少一个终端的两个或多个预消毒部件的连接，组装或填充，每个端部用于附接到另一部件，以及用于执行这种连接的装置，同时保持部件的无菌性。 通过使用溶剂粘合技术，无线电频率封隔器，热封机或任何其它合适的工艺将接触部件粘合在一起，使得到的连接永久化。 连接优选在活性无菌区域内进行。 使用诸如MIN-EB TM的低电压电子束仪器，可以产生合适的无菌场球。 多个部件的末端保持在无菌场球体内，直到密封部件内的污染的可能性显着降低到工业上可接受的标准。

公开(公告)号：US20060110282A1

公开(公告)日：2006-05-25

申请号：US11323112

申请日：2005-12-30

申请人： Arnold Bilstad ,  Bradley Buchanan ,  Alan Martilla ,  Archie Woodworth

发明人： Arnold Bilstad ,  Bradley Buchanan ,  Alan Martilla ,  Archie Woodworth

IPC分类号： A61L2/14

CPC分类号： A61L2/00 ,  A61L2/08 ,  A61L2/087 ,  A61L2/14 ,  A61L2/208 ,  A61L2202/23 ,  A61L2202/24 ,  A61M39/18 ,  B29C65/02 ,  B29C65/04 ,  B29C65/103 ,  B29C65/4895 ,  B29C66/0018 ,  B29C66/1142 ,  B29C66/5221 ,  B29C66/5229 ,  B29C66/52293 ,  B29C66/52298 ,  B29C66/73921 ,  B29C66/81431 ,  B29C66/83221 ,  B29C66/857 ,  B29L2023/007 ,  B67C7/0073

摘要： The connection, assembly, or fill of two or more pre-sterilized components having at least one terminal end each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field. Using a low-voltage electron beam instrument, such as the MIN-EB™, a suitable sterile field sphere can be created. The terminal ends of the multiple components remain within the sterile field sphere until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

公开(公告)号：US20050161614A1

公开(公告)日：2005-07-28

申请号：US11011663

申请日：2004-12-14

申请人： Arnold Bilstad ,  Bradley Buchanan ,  Alan Martilla ,  Archie Woodworth

发明人： Arnold Bilstad ,  Bradley Buchanan ,  Alan Martilla ,  Archie Woodworth

IPC分类号： A61L2/24 ,  A61L2/00 ,  A61L2/08 ,  A61L2/10 ,  A61L2/14 ,  A61L2/20 ,  A61M39/18 ,  B29C65/00 ,  B29C65/02 ,  B29C65/04 ,  B29C65/10 ,  B29C65/48 ,  B67C7/00

CPC分类号： A61L2/00 ,  A61L2/08 ,  A61L2/087 ,  A61L2/14 ,  A61L2/208 ,  A61L2202/23 ,  A61L2202/24 ,  A61M39/18 ,  B29C65/02 ,  B29C65/04 ,  B29C65/103 ,  B29C65/4895 ,  B29C66/0018 ,  B29C66/1142 ,  B29C66/5221 ,  B29C66/5229 ,  B29C66/52293 ,  B29C66/52298 ,  B29C66/73921 ,  B29C66/81431 ,  B29C66/83221 ,  B29C66/857 ,  B29L2023/007 ,  B67C7/0073

摘要： The connection, assembly, or fill of two or more pre-sterilized components 10, 12 having at least one terminal end 14 each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components 10, 12 together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field 60. Using a low-voltage electron beam instrument 54, such as the MIN-EB™, a suitable sterile field sphere can be created. The terminal ends 14 of the multiple components 10, 12 remain within the sterile field sphere 60 until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

摘要翻译： 公开了具有至少一个终端14的两个或更多个预消毒部件10,12的连接，组装或填充，每个终端14用于附接到另一部件，以及用于执行这种连接的装置，同时保持部件的无菌性 。 通过使用溶剂粘合技术，射频封口机，热封机或任何其它合适的工艺将接触部件10,12粘合在一起，使得到的连接永久化。 该连接优选地在活性无菌区域60内进行。使用诸如MIN-EB TM的低电压电子束仪器54可以产生合适的无菌场球。 多个部件10,12的末端14保持在无菌球体60内，直到密封部件内的污染的可能性明显地降低到工业上可接受的标准。

公开(公告)号：US07358505B2

公开(公告)日：2008-04-15

申请号：US10744946

申请日：2003-12-23

申请人： Archie Woodworth ,  William Reed ,  David J. Adams ,  John A. Martine, Jr. ,  Jeffery Smith ,  Michael Steeber ,  Kim Korzeniewski

发明人： Archie Woodworth ,  William Reed ,  David J. Adams ,  John A. Martine, Jr. ,  Jeffery Smith ,  Michael Steeber ,  Kim Korzeniewski

IPC分类号： A61L2/08

CPC分类号： A61J1/2089 ,  A61J1/10 ,  A61J1/1406 ,  A61J1/1475 ,  A61J1/201 ,  A61J1/2013 ,  A61J1/2051 ,  A61J1/2055 ,  A61L2/00 ,  A61L2/087 ,  A61L2202/23 ,  A61M39/18 ,  A61M2039/1027 ,  A61M2039/1077

摘要： What is disclosed is an apparatus and method for assembling a reconstitution assembly (1) having a reconstitution device (10) having a first end connected to a flexible diluent container (12), the reconstitution device (10) having a second end connected to a drug vial (14). The reconstitution device (10) and containers, such as drug vials (14) or diluent bags (12), are loaded onto positioning assemblies (27) on a conveyor (90). The positioning assemblies (27) are conveyed to sterilization booths (270). Sterilization fields are generated within the sterilization booths (270), and the containers are sterilely connected to the reconstitution device (10) within the sterile fields.

摘要翻译： 所公开的是用于组装具有重构装置（10）的重构组件（1）的装置和方法，所述重构装置具有连接到柔性稀释剂容器（12）的第一端，所述重构装置（10）的第二端连接到 药瓶（14）。 重建装置（10）和诸如药物小瓶（14）或稀释袋（12）的容器被装载到传送器（90）上的定位组件（27）上。 定位组件（27）被输送到灭菌室（270）。 消毒场在灭菌室（270）内产生，容器与无菌区内的重建装置（10）无菌连接。

公开(公告)号：US07264771B2

公开(公告)日：2007-09-04

申请号：US09294964

申请日：1999-04-20

申请人： Arnold C. Bilstad ,  Bradley H. Buchanan ,  Alan W. Martilla ,  Archie Woodworth

发明人： Arnold C. Bilstad ,  Bradley H. Buchanan ,  Alan W. Martilla ,  Archie Woodworth

IPC分类号： A61L2/00

CPC分类号： A61L2/00 ,  A61L2/08 ,  A61L2/087 ,  A61L2/14 ,  A61L2/208 ,  A61L2202/23 ,  A61L2202/24 ,  A61M39/18 ,  B29C65/02 ,  B29C65/04 ,  B29C65/103 ,  B29C65/4895 ,  B29C66/0018 ,  B29C66/1142 ,  B29C66/5221 ,  B29C66/5229 ,  B29C66/52293 ,  B29C66/52298 ,  B29C66/73921 ,  B29C66/81431 ,  B29C66/83221 ,  B29C66/857 ,  B29L2023/007 ,  B67C7/0073

摘要： The connection, assembly, or fill of two or more pre-sterilized components having at least one terminal end each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field. Using a low-voltage electron beam instrument, such as the MIN-EB™, a suitable sterile field sphere can be created. The terminal ends of the multiple components remain within the sterile field sphere until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

摘要翻译： 公开了具有至少一个终端的两个或多个预消毒部件的连接，组装或填充，每个端部用于附接到另一部件，以及用于执行这种连接的装置，同时保持部件的无菌性。 通过使用溶剂粘合技术，无线电频率封隔器，热封机或任何其它合适的工艺将接触部件粘合在一起，使得到的连接永久化。 连接优选在活性无菌区域内进行。 使用诸如MIN-EB TM的低电压电子束仪器，可以产生合适的无菌场球。 多个部件的末端保持在无菌场球体内，直到密封部件内的污染的可能性显着降低到工业上可接受的标准。